The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Baxter Infusor Sv (small Volume); Baxter Infusor Lv (large Volume).
| Device ID | K041738 |
| 510k Number | K041738 |
| Device Name: | BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) |
| Classification | Pump, Infusion |
| Applicant | BAXTER HEALTHCARE CORPORATION ROUTE 120 AND WILSON RD. Round Lake, IL 60073 -0490 |
| Contact | Karen Spranger |
| Correspondent | Karen Spranger BAXTER HEALTHCARE CORPORATION ROUTE 120 AND WILSON RD. Round Lake, IL 60073 -0490 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-28 |
| Decision Date | 2004-07-09 |
| Summary: | summary |